PedaleoVR: Usability study of a virtual reality application for cycling exercise in patients with lower limb disorders and elderly people

Achieving adherence to physical exercise training is essential in elders and adults with neurological disorders. Immersive technologies are seeing wide adoption among new neurorehabilitation therapies, as they provide a highly effective motivational and stimulating component. The aim of this study is to verify whether the developed virtual reality system for pedaling exercise is accepted and could be safety, useful and motivating for these populations. A feasibility study was conducted with patients with neuromotor disorders and elderly people from Lescer Clinic and the residential group Albertia, respectively. All the participants performed a pedaling exercise session with virtual reality platform. Then, the Intrinsic Motivation Inventory, the System Usability Scale (SUS), Credibility and Expectancy Questionnaire, were assessed in the group of 20 adults (mean age = 61.1; standard deviation = 12.617, 15 males and 5 females) with lower limb disorders. While the Simulator Sickness Questionnaire, Presence Questionnaire, Game user Experience Satisfaction Scale and SUS were assessed in the group of 18 elders (mean age = 85.16; standard deviation = 5.93, 5 males and 13 females). In light of the outcomes, PedaleoVR is considered to be a credible, usable and motivational tool towards adults with neuromotor disorders to perform cycling exercise, and therefore its usage could contribute to adherence to lower limb training activities. Moreover, PedaleoVR does not generate negative effects related to cybersickness while the sensation of presence and the degree of satisfaction generated have been positively evaluated by the geriatric population. This trial has been registered at ClinicalTrials.gov under the identifier: NCT05162040, Dec 2021


Introduction
Background 2 Scientific background and explanation of rationale Theories used in designing behavioral interventions X 2-3

Participants 3
Eligibility criteria for participants, including criteria at different levels in recruitment/sampling plan (e.g., cities, clinics, subjects) o Unit of delivery: how were the subjects grouped during delivery? o Exposure quantity and duration: how many sessions or episodes or events were intended to be delivered? How long were they intended to last?

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o Time span: how long was it intended to take to deliver the intervention to each unit?

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o Activities to increase compliance or adherence (e.g., incentives) X 5 Objectives 5 Specific objectives and hypotheses X 3 Outcomes 6 Clearly defined primary and secondary outcome measures Methods used to collect data and any methods used to enhance the quality of measurements Information on validated instruments such as psychometric and biometric properties X 6-8 Sample Size 7 How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules X 8 Assignment Method 8 Unit of assignment (the unit being assigned to study condition, e.g., individual, group, community)

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Method used to assign units to study conditions, including details of any restriction (e.g., blocking, stratification, minimization)

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Inclusion of aspects employed to help minimize potential bias induced due to non-randomization (e.g., matching) -Blinding (masking) 9 Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to study condition assignment; if so, statement regarding how the blinding was accomplished and how it was assessed.
-Unit of Analysis 10 Description of the smallest unit that is being analyzed to assess intervention effects (e.g., individual, group, or community) If the unit of analysis differs from the unit of assignment, the analytical method used to account for this (e.g., adjusting the standard error estimates by the design effect or using multilevel analysis) -Statistical Methods

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Statistical methods used to compare study groups for primary methods outcome(s), including complex methods of correlated data -Statistical methods used for additional analyses, such as a subgroup analyses and adjusted analysis X 8 Methods for imputing missing data, if used -Statistical software or programs used X 8

Participant flow 12
Flow of participants through each stage of the study: enrollment, assignment, allocation, and intervention exposure, follow-up, analysis (a diagram is strongly recommended)

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o Enrollment: the numbers of participants screened for eligibility, found to be eligible or not eligible, declined to be enrolled, and enrolled in the study

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o Assignment: the numbers of participants assigned to a study condition Data on study group equivalence at baseline and statistical methods used to control for baseline differences Numbers analyzed 16 Number of participants (denominator) included in each analysis for each study condition, particularly when the denominators change for different outcomes; statement of the results in absolute numbers when feasible -Indication of whether the analysis strategy was "intention to treat" or, if not, description of how non-compliers were treated in the analyses -

Outcomes and estimation 17
For each primary and secondary outcome, a summary of results for each estimation study condition, and the estimated effect size and a confidence interval to indicate the precision -Inclusion of null and negative findings -Inclusion of results from testing pre-specified causal pathways through which the intervention was intended to operate, if any